Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:December 11, 2018
End Date:November 2021
Contact:Sean T Daly
Email:sean.daly@anchiano.com
Phone:857-277-5577

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A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin

This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter
clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately
treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to
the US Food and Drug Administration (FDA) guidance.

BC-819 (inodiftagene vixteplasmid) is a recombinant DNA plasmid that directs the expression
of a potent toxin specifically in malignant cells but not in normal tissue. It has been
designed to exploit the established biology of the H19 gene, which is upregulated and
expressed at high levels only in malignant cells, to produce bacterial diphtheria toxin only
in bladder cancer tissue. BC-819 is administered directly into the bladder to enable maximal
topical exposure to target bladder cancer cells.

Inclusion Criteria:

1. Male or female patients ≥18 years of age at the time of consent

2. Patient must have been adequately treated with BCG defined as at least one of the
following (FDA 2018):

1. At least five of six doses of an initial induction course plus at least two of
three doses of maintenance therapy

2. At least five of six doses of an initial induction course plus at least two of
six doses of a second induction course

3. A single course of induction BCG can qualify if the patient has T1 high-grade
disease at first evaluation (see 3c)

3. Patient must be BCG-unresponsive defined as at least one of the following (FDA 2018):

1. Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12
months of completion of adequate BCG therapy. An assessment within 15 months can
also qualify when no assessment was done 12 months after completion of adequate
BCG therapy.

2. Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG
therapy. An assessment within 9 months can also qualify when no assessment was
done 6 months after completion of adequate BCG therapy.

3. T1 high-grade disease at the first evaluation following a single course of
induction BCG qualifies (Lerner et al. 2015, Steinberg et al. 2016)

4. Patient must have, at study entry, NMIBC indicated by 1 or more of the following:

1. Ta or T1 high-grade disease

2. CIS disease

5. Patient must have no known evidence of concomitant upper tract urothelial carcinoma or
urothelial carcinoma within the prostatic urethra within 6 months of enrollment

6. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

7. Patient must have adequate hematologic function, as demonstrated by the following:

1. Hemoglobin level ≥10 g/dL

2. Absolute neutrophil count ≥1.5 x 109/L

3. Platelet count ≥100 x 109/L

8. Patient must have adequate liver and renal function as demonstrated by the following:

1. Aspartate aminotransferase and alanine aminotransferase each ≤3.0 x upper limit
of normal

2. Total bilirubin ≤1.5 x upper limit of normal, unless prior documentation of
Gilbert's syndrome in which case, 3.0 mg/dL is allowed

3. Serum creatinine ≤1.5 x upper limit of normal or measured or calculated
creatinine clearance ≥30 mL/min

9. Female patients of childbearing potential must use maximally effective birth control
during the period of therapy and for 1 month after the last study drug infusion

10. Male patients who are sexually active must be willing to use a double barrier
contraceptive method upon study enrollment, during the course of the study, and for 1
month after the last study drug infusion

Exclusion Criteria:

1. Patient has current or previous evidence of muscle invasive (muscularis propria) or
metastatic bladder cancer disease

2. Patient has received prior investigational therapy for NMIBC

3. Patient has received any therapy for NMIBC within 10 weeks before the start of study
treatment other than surgical resection, 1 dose of chemotherapy, and previous BCG

4. Patient is intolerant to previous BCG treatment in the absence of meeting other
criteria for BCG unresponsiveness and adequate BCG therapy

5. Patient has received external beam radiation therapy for bladder cancer at any time or
for any other condition

6. Patient has an active infection, including urinary tract infection (viral, bacterial,
or fungal) and cystitis

7. Patient has urinary tract signs or symptoms that preclude retention of drug in the
bladder; this does not include anticholinergic drugs

8. Patient is known to have tested positive for human immunodeficiency virus (HIV). No
HIV testing is required if patient is not known have tested positive

9. Patient is female and is pregnant or breastfeeding

10. Patient has a known presence or history of malignancy of other organ system within the
5 years before study start, with the exception of non-melanoma skin cancer; very low
or low-risk prostate cancer; or patients who have been disease free for at least 2
years following stage 1 or 2 cancer
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Richmond, Virginia 23235
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
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Durham, North Carolina 27710
(919) 684-8111
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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Sacramento, California 95814
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Baltimore, Maryland 21205
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Belleville, New Jersey 08043
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
312.355.1625
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Coeur d'Alene, Idaho 83814
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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Gilbert, Arizona 85234
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Grand Rapids, Michigan 69546
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Greensboro, North Carolina
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11 Park Creek Drive
Greenville, South Carolina 29605
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1 Baylor Plaza
Houston, Texas 77030
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1301 Jayhawk Boulevard
Lawrence, Kansas 66045
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Little Rock, Arkansas 72211
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1 Medical Center Drive
Morgantown, West Virginia 26506
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Nampa, Idaho 83642
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Nashville, Tennessee 37209
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New Orleans, Louisiana 70112
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New Orleans, Louisiana 70121
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Phoenix, Arizona 85054
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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750 East Adams Street
Syracuse, New York 13210
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Virginia Beach, Virginia 23462
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Voorhees, New Jersey 08403
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